Umbilical Cord Blood Stem Cell Transplantation in Adults With Advanced Blood Disorders or Cancer

NCT00312429 | Completed Phase 1

• 2 other identifiers: 2166R01HL062095-06
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Umbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this procedure in adults. The purpose of this study is to examine the immune system response to cord blood stem cell transplantation in adults with advanced blood disorders or cancer.

Conditions

Hematologic Neoplasms

Keywords

Hematological Malignancies; Leukemia; Lymphoma; Myelodysplasia; Multiple Myeloma

Outcome Measures

Secondary Outcomes (1)

• Survival Rates

  Year 1

Interventions

Stem Cell Transplantation PROCEDURE

Allogeneic umbilical cord blood stem cell transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis reviewed at transplant center and confirmed to fit the criterion for high risk blood disease or cancer, as defined for the study
• Estimated life expectancy of at least 6 weeks following study entry
• Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
• White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results reviewed by transplant center
• Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT) performed and reviewed by transplant center (for individuals with an ejection fraction and diffusing capacity \[DLCO\] of 40-50%, the appropriate cardiology or pulmonary consultations should be considered if the individual has severe heart or lung disease at the initiation of therapy)
• Sufficient number of umbilical cord blood units available for transplantation
• If female, willing to use contraception throughout the study

You may not qualify if:

• Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry
• Diagnosed with a medical or psychiatric illness that may interfere with study participation
• Pregnant

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Anemia, Refractory, with Excess of Blasts; Multiple Myeloma

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Nelson J. Chao, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2006
• First Posted: April 10, 2006
• Study Start: January 1, 2002
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

US (1)